Actively Recruiting
Conversion to Carfilzomib Therapy in Bortezomib Intolerant Newly Diagnosed Multiple Myeloma(NDMM) Patients
Led by The First Affiliated Hospital of Soochow University · Updated on 2024-11-12
50
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, single-arm, prospective study conducted in real-world clinical practice. It aims to evaluate the efficacy and safety in Chinese patients with newly diagnosed multiple myeloma who switch to carfilzomib-based regimens after bortezomib-based triple-drug regimen intolerance happens.
CONDITIONS
Official Title
Conversion to Carfilzomib Therapy in Bortezomib Intolerant Newly Diagnosed Multiple Myeloma(NDMM) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with multiple myeloma according to IMWG criteria
- Received only first-line bortezomib-based triple therapy (VRD, VTD, VCD, or PAD)
- ECOG performance status score between 0 and 2
- Developed bortezomib-related toxicities including Grade 1 with pain or Grade 2 peripheral neuropathy, Grade 3 liver impairment, Grade 3 diarrhea, or other Grade 3 non-hematologic adverse events leading to dose reduction or discontinuation of bortezomib
- Willing and able to sign informed consent to participate in the study
You will not qualify if you...
- Currently participating in other interventional clinical studies (non-interventional observational studies allowed)
- Prior treatment with carfilzomib or participation in carfilzomib studies
- Diagnosis of multiple myeloma combined with plasma cell leukemia (≥5% monoclonal plasma cells in peripheral blood)
- Not fully recovered from prior chemotherapy toxicities (greater than grade 1)
- Other malignancies diagnosed before multiple myeloma, except certain skin and cervical or breast cancers cured within 3 years with low recurrence risk
- Active systemic infection, active hepatitis B or C, or positive HIV test
- Uncontrolled cardiovascular disease including severe arrhythmias, recent heart attack or unstable angina, NYHA class III or IV heart failure, or left ventricular ejection fraction below 40%
- Known chronic obstructive pulmonary disease with FEV1 less than 50%, persistent asthma, or asthma history within the past 2 years
- Unable to comply with study procedures
- Hypersensitivity to carfilzomib or its ingredients
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Lingzhi Yan
Suzhou, Jiangsu, China, 215006
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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